Clobazam

Product NDC
60687-423
11-digit product format
606870423
Labeler code
60687
Product ID
60687-423_3d5d1f23-c639-3604-e063-6294a90ac606
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209718
Marketing category
ANDA
Marketing start
2019-01-17
Substance
CLOBAZAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobazam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui199450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
713032fb-f461-4501-be8a-ca575cddec45Product name720211028
f324c243-b420-476a-968a-bb1445dcc148Product name120190211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-423-11Clobazam1 in 1 BLISTER PACKTABLET19
60687-423-21Clobazam30 in 1 BOX, UNIT-DOSETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-423-11EA - Each60687-423152c1568-3487-4abe-a53b-86838488033f12019-02-13
60687-423-21EA - Each60687-4236449c100-0733-4b14-9c3c-55744c64bd0812019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-423CLOBAZAM TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20241013_8fce3252-95f8-4428-9922-5ba308e20177.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSN8fce3252-95f8-4428-9922-5ba308e201779
199450clobazam 10 MG Oral TabletSCD8fce3252-95f8-4428-9922-5ba308e201779

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-423-11606870423111 in 1 BLISTER PACKHistorical
60687-423-216068704232130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21) / 1 TABLET in 1 BLISTER PACK (60687-423-11) 30 blister pack2019-01-170000-00-00NoNoCurrent